Geographic variations in the PARADIGM-HF heart failure trial.
Geographic variations in the PARADIGM-HF heart failure trial.
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DOI：
10.1093/eurheartj/ehw226
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发表时间：
2016-11-01
影响因子：
39.3
通讯作者：
McMurray JJ
中科院分区：
文献类型：
--
作者：
Kristensen SL;Martinez F;Jhund PS;Arango JL;Bĕlohlávek J;Boytsov S;Cabrera W;Gomez E;Hagège AA;Huang J;Kiatchoosakun S;Kim KS;Mendoza I;Senni M;Squire IB;Vinereanu D;Wong RC;Gong J;Lefkowitz MP;Rizkala AR;Rouleau JL;Shi VC;Solomon SD;Swedberg K;Zile MR;Packer M;McMurray JJ
临床试验的全球化突出了患者特征、事件发生率和治疗效果的地理差异。我们在PARADIGM-HF中进一步研究了这些，PARADIGM-HF是迄今为止最大和最具全球代表性的心力衰竭（HF）试验。我们看了五个地区：北美（NA）602（8%），西欧（WE）1680（20%），中欧/东欧/俄罗斯（CEER）2762（33%），拉丁美洲（LA）1433（17%）和亚太地区（AP）1487（18%）。显著差异包括：WE患者（平均年龄68岁）和NA患者（65岁）的年龄大于AP患者（58岁）和LA患者（63岁），并且患有更多的冠状动脉疾病; NA和CEER患者的体征、症状和功能状态最差。北美患者最有可能使用起搏器（54 vs. 2% AP），最不可能使用盐皮质激素受体拮抗剂（36 vs. 65% LA）。其他循证治疗在NA和WE中使用最频繁。心血管（CV）死亡或HF住院（每100患者年）的主要复合结局发生率因地区而异：NA 13.6（95%CI 11.7-15.7）WE 9.6（8.6-10.6）、CEER 12.3（11.4-13.2）、LA 11.2（10.0-12.5）和AP 12.5（11.3-13.8）。校正预后变量后，相对于NA，LA和AP的CV死亡风险较高，WE的HF住院风险较低。沙库巴曲/缬沙坦的获益在各地区一致。PARADIGM-HF有许多地区差异，包括年龄、症状、合并症、背景治疗和事件发生率，尽管这些并没有改变沙库巴曲/缬沙坦的获益。 http://www.clinicaltrials.gov唯一标识符：NCT 01035255。
The globalization of clinical trials has highlighted geographic variations in patient characteristics, event rates, and treatment effects. We investigated these further in PARADIGM-HF, the largest and most globally representative trial in heart failure (HF) to date. We looked at five regions: North America (NA) 602 (8%), Western Europe (WE) 1680 (20%), Central/Eastern Europe/Russia (CEER) 2762 (33%), Latin America (LA) 1433 (17%), and Asia-Pacific (AP) 1487 (18%). Notable differences included: WE patients (mean age 68 years) and NA (65 years) were older than AP (58 years) and LA (63 years) and had more coronary disease; NA and CEER patients had the worst signs, symptoms, and functional status. North American patients were the most likely to have a defibrillating-device (54 vs. 2% AP) and least likely prescribed a mineralocorticoid receptor antagonist (36 vs. 65% LA). Other evidence-based therapies were used most frequently in NA and WE. Rates of the primary composite outcome of cardiovascular (CV) death or HF hospitalization (per 100 patient-years) varied among regions: NA 13.6 (95% CI 11.7–15.7) WE 9.6 (8.6–10.6), CEER 12.3 (11.4–13.2), LA 11.2 (10.0–12.5), and AP 12.5 (11.3–13.8). After adjustment for prognostic variables, relative to NA, the risk of CV death was higher in LA and AP and the risk of HF hospitalization lower in WE. The benefit of sacubitril/valsartan was consistent across regions. There were many regional differences in PARADIGM-HF, including in age, symptoms, comorbidity, background therapy, and event-rates, although these did not modify the benefit of sacubitril/valsartan. http://www.clinicaltrials.gov. Unique identifier: NCT01035255.
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影响因子：
168.9
作者：
Cleland, JGF;Cohen-Solal, A;Widimsky, J
通讯作者：
Widimsky, J
影响因子：
18.2
作者：
McMurray, John J. V.;Packer, Milton;Desai, Akshay S.;Gong, Jianjian;Lefkowitz, Martin;Rizkala, Adel R.;Rouleau, Jean L.;Shi, Victor C.;Solomon, Scott D.;Swedberg, Karl;Zile, Michael R.
通讯作者：
Zile, Michael R.
影响因子：
37.8
作者：
Kristensen, Soren L.;Kober, Lars;McMurray, John J. V.
通讯作者：
McMurray, John J. V.
影响因子：
13
作者：
Rush, Christopher J.;Campbell, Ross T.;McMurray, John J. V.
通讯作者：
McMurray, John J. V.
影响因子：
18.2
作者：
McMurray, John J. V.;Packer, Milton;Zile, Michael R.
通讯作者：
Zile, Michael R.